China pharmaceutical industry is growing at exceptional speed. Central government has encouraged bio-industry as a key segment in its industry policy. One of its policies is to establish 22 of national bio-industry park in China, and to promote, incubate and support bio-industry from local and global area. Many global players have already set up their R&D center there focusing on the big market. In addition, more than 100 bioventures have been established. I believe that a blockbuster product originated in China will be born in the near future.

Indonesia, with over 238 million people and 10% average annual GMP growth in the recent years, has huge potential and is definitely a future market for world players in the pharmaceutical industry. In this lecture, a representative from the National Board of the Indonesian Pharmaceutical Association will provide a broad overview of the US$3.9 billion pharma market, with reference to pharmaceutical legislation, the drug price system, the insurance system, and the drug distribution system.

A general description of the philosophy of quality control in pharmaceutical ingredient manufacture in Japan, guideline principles from regulatory authorities in recent years, and recommendation guidelines from regulatory authorities for the ICH agreement item Q Trio, which means the three series (Q8, Q9, Q10) prescribed by ICH. In addition, within the globalizing pharmaceutical manufacturing industry, the participation of Japan in PICs and corresponding measures taken by Japanese makers, discussions in ICHQ11, and inspection trends by overseas regulatory authorities will be explained, together with an introduction of overseas rivals’ trends in India and China and issues that must be addressed by the Japanese industry.

Guideline on management of computerized systems for marketing authorization holders and manufacturers of drugs and quasi-drugs, issued by the Ministry of Health, Labour and Welfare shall come into force on this April, requiring proper control of computerized systems for the production of active pharmaceutical ingredients. This lecture will explain the basic concepts of the guidelines, the main points for compliance with the guidelines, and the management of the computerized systems concerned.

My presentation will be made not only from the global CMC regulatory perspective, but also from the actual manufacturing operation. In particular, my presentation will be made on how to consider and handle their ‘physicochemical properties’ including the selection of salt form, particle size, polymorphism, related substances (e.g., toxicity), etc. in a scale-up of the manufacturing process. And I would like to touch upon the ‘starting material,’ ‘purification in the final process,’ and the ‘linkage of drug substance with drug product.’

Following requirements of ICHQ-trio, NDA with QbD concepts has been increased in Japanese pharmaceutical society. Some companies have selected RTRt with PAT analyzers as a control strategy after risk assessments of manufacturing processes. In my presentation, challenge and future perspective of RTRt with PAT analyzers will be discussed.

Recently, we are facing the dynamic "CHANGE" in the world of Chemical Substance Management. Following the EU REACH, Japan Kashinhou amended in April 2010, China amended to "China REACH" in October 2010. In Korea, new regulation on chemical substances registration (Korea REACH) is planned to enforce. Apposite information collection of regulatory compliance and the exact decision are crucial for global business.